Dextenza in the Post-op Management of Vitreoretinal Surgeries

Post-operative Pain Clinical Trial

Official title:

Intracanalicular Dexamethasone Insert for Management of Post-operative Pain and Inflammation in Patients Undergoing Vitreoretinal Surgery

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04371445
• Other study ID #: 4-29-2020
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: December 1, 2020
• Est. completion date: June 1, 2024

Study information

• Verified date: January 2023
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will assess the control of inflammation at days 1, 7, 14, and 21 days following the vitreoretinal surgical procedure analyzing two randomized study arms: Intracanalicular dexamethasone insert group or topical steroid drop group.

Patients must be 18 years of age and older, of any race and either sex, requiring surgery with the procedure type of pars plana vitrectomy for either the indication of macular hole, epiretinal membrane removal, or vitreomacular traction.

Description:

Topical steroids are the current standard of care for managing postoperative pain and inflammation following vitreoretinal surgery. However, topical treatments are limited by the potential for patient non-adherence and variation in drug concentrations due to the intermittent nature of application. A corticosteroid insert, placed following surgery, provides the advantages of reliable and continuous drug delivery without the need for patients to adhere to a treatment regimen. Recently, DEXTENZA®, a dexamethasone intracanalicular insert was FDA-approved for the treatment of inflammation and pain following ophthalmic surgery. DEXTENZA® is placed into the canaliculus via the lower punctum and is designed to release steroid medication for 30 days.

The data is limited regarding the safety and efficacy of DEXTENZA® for postoperative management of vitreoretinal surgery. Herein, the aim of this study is to assess the management of pain and inflammation following retinal surgery when using a dexamethasone implant compared with topical steroids.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: June 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men and women >18 years old

• Planning to undergo vitreoretinal surgery with the procedure type of pars plana vitrectomy for either the indication of macular hole, epiretinal membrane removal, or vitreomacular traction.

Exclusion Criteria:

• Patients undergoing combined cataract or glaucoma procedure, intraocular lens exchange, scleral buckle, and/or implant of a drug delivery system

• History of complications, trauma, adverse events, disease in nasolacrimal region, including dacryocystitis, canaliculitis in either eye

• Structural lid abnormalities such as ectropion or entropion in surgical eye

• Ongoing use of systemic narcotic pain relievers

• Presence of any intraocular inflammation (cells and flare) in the study eye at screening/baseline

• Pain score greater than "0" on the ocular pain assessment in the study eye at screening/baseline

• Active or chronic or recurrent uncontrolled ocular or systemic inflammatory disease, including diabetes

• Other ocular surgeries or procedures during the study period and/or 6 months prior

• Intraoperative complications

• Patients with history of glaucoma (defined as glaucoma requiring 2 or more drops, IOP at baseline greater than 25, or advanced optic nerve cupping). Patients with glaucoma or ocular hypertension controlled with a single drop can be enrolled.

• Patients with a known hypersensitivity to NSAIDs or steroids or any component of the study medication.

• Have used ocular, topical, or systemic NSAIDs within 7 days prior to procedure and during surgery.

• Use of intracameral or subconjunctival NSAIDs or steroids intraoperatively.

• Have used topical, ocular, inhaled or systemic steroids within 14 days prior to procedure

• Are pregnant or nursing/lactating

• Participation as a subject in any clinical study within the 30 days prior to randomization.

• Surgeries using 20 gauge or 23 gauge instruments.

Related Conditions & MeSH terms

• Inflammation
• Ocular Inflammation
• Pain, Postoperative
• Post-Operative Inflammation
• Post-operative Pain
• Vitreoretinal Surgery

Intervention

Drug:
• Dexamethasone Ophthalmic Insert
DEXTENZA® is a 3mm long gel-like cylinder that is inserted in the punctum, a natural opening in the lower eyelid. DEXTENZA® is activated by the eye's moisture. DEXTENZA® delivers 0.4 mg dexamethasone, a liquid corticosteroid, onto the surface of the eye automatically for up to 30 days after eye surgery. Dexamethasone is used to reduce inflammation and eye pain. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen.DEXTENZA® is a 3mm long gel-like cylinder that is inserted in the punctum, a natural opening in the lower eyelid. DEXTENZA® is activated by the eye's moisture. DEXTENZA® delivers 0.4 mg dexamethasone, a liquid corticosteroid, onto the surface of the eye automatically for up to 30 days after eye surgery. Dexamethasone is used to reduce inflammation and eye pain. This arm will also receive the standard of care including topical antibiotics.
• Prednisolone Acetate 1% Oph Susp
Prednisolone acetate 1% eye drops are used 2-4 times daily for 30 days as the current standard of care for treating inflammation and eye pain after cataract surgery. Prednisolone, like dexamethasone, is a steroid. This arm will also receive the standard of care including topical antibiotics.

Locations

Country	Name	City	State
United States	Cole Eye Institute, Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	Ocular Therapeutix, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (5)

An JA, Kasner O, Samek DA, Levesque V. Evaluation of eyedrop administration by inexperienced patients after cataract surgery. J Cataract Refract Surg. 2014 Nov;40(11):1857-61. doi: 10.1016/j.jcrs.2014.02.037. Epub 2014 Sep 22. — View Citation

Gira JP, Sampson R, Silverstein SM, Walters TR, Metzinger JL, Talamo JH. Evaluating the patient experience after implantation of a 0.4 mg sustained release dexamethasone intracanalicular insert (Dextenza): results of a qualitative survey. Patient Prefer Adherence. 2017 Mar 8;11:487-494. doi: 10.2147/PPA.S126283. eCollection 2017. — View Citation

Hermann MM, Ustundag C, Diestelhorst M. Electronic compliance monitoring of topical treatment after ophthalmic surgery. Int Ophthalmol. 2010 Aug;30(4):385-90. doi: 10.1007/s10792-010-9362-3. Epub 2010 Apr 7. — View Citation

Jabs DA, Nussenblatt RB, Rosenbaum JT; Standardization of Uveitis Nomenclature (SUN) Working Group. Standardization of uveitis nomenclature for reporting clinical data. Results of the First International Workshop. Am J Ophthalmol. 2005 Sep;140(3):509-16. doi: 10.1016/j.ajo.2005.03.057. — View Citation

Tyson SL, Bafna S, Gira JP, Goldberg DF, Jones JJ, Jones MP, Kim JK, Martel JM, Nordlund ML, Piovanetti-Perez IK, Singh IP, Metzinger JL, Mulani D, Sane S, Talamo JH, Goldstein MH; Dextenza Study Group. Multicenter randomized phase 3 study of a sustained-release intracanalicular dexamethasone insert for treatment of ocular inflammation and pain after cataract surgery. J Cataract Refract Surg. 2019 Feb;45(2):204-212. doi: 10.1016/j.jcrs.2018.09.023. Epub 2018 Oct 24. Erratum In: J Cataract Refract Surg. 2019 Jun;45(6):895. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess control of inflammation following the vitreoretinal surgical procedure.	Percentage of patients with Inflammation following surgery as assessed from 0-4+ cell and flare based on the Standardization of Uveitis Nomenclature [SUN] Working Group grading scheme at day 14	day 14 following surgery
Secondary	The patient reporting of pain following surgery using visual analog pain scale at days 1, 3, 7, 14, and 21 following surgery.	Pain following surgery will be measured using a scale from 0 to10 (0 = no pain, 10 = severe pain that prevents performing activities of daily living). Higher scores mean a worse outcome.	days 1, 3, 7, 14, and 21 following surgery
Secondary	Inflammation assessed on Anterior Segment OCT by masked grading at days 1, 7, 14, and 21 following surgery.	Anterior segment will be assessed using a continuous variable (cells/mm3).	days 1, 7, 14, and 21 following surgery
Secondary	Mean change in Best Corrected Visual Acuity (BCVA) from baseline to day 21 following surgery.	BCVA was assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) method.	day 21 following surgery
Secondary	% of patients with rebound inflammation defined as a two-step worsening of inflammation by SUN grading.		day 21 following surgery
Secondary	% of patients receiving rescue treatment.		days 1, 7, 14, and 21 following surgery
Secondary	% of patients with postoperative management via telephone or electronic messaging		day 21 following surgery
Secondary	The incidence and severity of ocular and non-ocular adverse events (AEs) and serious AEs between arms.		day 21 following surgery